Trial · NCT07878026
Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
NCT07878026, Early phase 1, Not yet recruiting, Jinling Hospital, China
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC). Trials, record NCT07878026. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07878026
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Oral Aeromonas sp. MTB Phage Therapy for Pouchitis in Patients With Ulcerative Colitis (UC)
- NCT number
- NCT07878026
- Status
- Not yet recruiting
- Phases
- Early phase 1
- Enrollment
- 12 participants, estimated
- Lead sponsor
- Jinling Hospital, China
- Conditions
- Pouchitis, UC - Ulcerative Colitis
- Interventions
- MTB-targeted phage therapy
- First posted
- 2026-10-16
- Last updated
- 2026-10-22
Source ClinicalTrials.gov
Registered outcomes11
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of participants with a decrease in Modified Pouchitis Disease Activity Index (mPDAI) total score from baseline to week 14 | Baseline to Week 14 | The severity of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). The mPDAI was used to evaluate patients' clinical symptoms (including stool frequency, rectal bleeding, fecal urgency, abdominal cramps, and presence of fever) and endoscopic inflammation (edema, granularity, fragility, loss of the vascular pattern, mucous exudates, and ulceration) . The percentage of participants with a decrease in mPDAI total score from baseline to Week 14 will be evaluated. A decrease in mPDAI total score is defined as a Week 14 mPDAI total score lower than the baseline mPDAI total score. |
| Secondary | Percentage of Participants in Clinical Remission at Week 14 Based on the Modified Pouchitis Disease Activity Index (mPDAI) | Week 14 | Clinical remission of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The percentage of participants who meet the criteria for clinical remission at Week 14 will be evaluated. |
| Secondary | Percentage of Participants in Clinical Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index (mPDAI) | Week 34 | Clinical remission of pouchitis will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The outcome will be reported as the percentage (%) of participants who meet both criteria for clinical remission at Week 34. |
| Secondary | Percentage of Participants With Sustained Clinical Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index (mPDAI) | Week 14 through Week 34 | Sustained clinical remission will be assessed using the modified Pouchitis Disease Activity Index (mPDAI). Sustained clinical remission is defined as clinical remission at both Week 14 and Week 34. Clinical remission is defined as an mPDAI score ≤4 points and a decrease of ≥2 points from baseline. The percentage of participants who meet the criteria for sustained clinical remission at Week 34 will be evaluated. |
| Secondary | Percentage of Participants in Endoscopic Remission at Week 14 Based on the Modified Pouchitis Disease Activity Index Endoscopic Subscore (mPDAI-E) | Week 14 | Endoscopic remission will be assessed by endoscopic evaluation of the pouch. Endoscopic remission is defined as normalization of the mucosal appearance, clear vascular pattern, and absence of exudate or secretions.mPDAI-E≤1. The outcome will be reported as the percentage (%) of participants who meet the criteria for endoscopic remission at Week 14. |
| Secondary | Percentage of Participants in Endoscopic Remission at Week 34 Based on the Modified Pouchitis Disease Activity Index Endoscopic Subscore (mPDAI-E) | Week 34 | Endoscopic remission will be assessed by endoscopic evaluation of the pouch. Endoscopic remission is defined as normalization of the mucosal appearance, clear vascular pattern, and absence of exudate or secretions.mPDAI-E≤1. The outcome will be reported as the percentage (%) of participants who meet the criteria for endoscopic remission at Week 34. |
| Secondary | Active MTB Phage Concentration in Fresh Stool Samples (PFU/g) | 24-48 hours after the first dose and Weeks 2, 8, 14, 24, and 34 | Active MTB phage concentration will be measured in fresh stool samples using a plaque assay. Approximately 1-2 g of fresh stool will be collected at each assessment. Active MTB phage concentration will be reported as plaque-forming units per gram of stool (PFU/g). Samples will be collected 24-48 hours after the first oral administration of MTB phage and at Weeks 2, 8, 14, 24, and 34. |
| Secondary | Fecal MTB Bacterial Abundance Measured by Culture (CFU/g) | Weeks 2, 8, 14, 24, and 34 | Fecal MTB bacterial abundance will be assessed by culture using an Aeromonas-selective culture medium. Fresh stool samples of approximately 1-2 g will be collected at Weeks 2, 8, 14, 24, and 34. MTB bacterial abundance will be reported as colony-forming units per gram of stool (CFU/g). |
| Secondary | Fecal MTB Bacterial Load Measured by Quantitative Polymerase Chain Reaction (qPCR) (CFU/mg) | Weeks 2, 8, 14, 24, and 34 | Fecal MTB bacterial load will be quantified using quantitative polymerase chain reaction (qPCR). Fresh stool samples of approximately 1-2 g will be collected at Weeks 2, 8, 14, 24, and 34. The qPCR cycle threshold (Ct) values will be converted to MTB bacterial load and reported as colony-forming units per milligram of stool (CFU/mg). |
| Secondary | Change in Inflammatory Bowel Disease Questionnaire (IBDQ) Total Score From Baseline to Week 34 (Points) | Baseline to Week 34 | Patient-reported quality of life will be assessed using the Inflammatory Bowel Disease Questionnaire (IBDQ). The change in IBDQ total score from baseline to Week 34 will be calculated by subtracting the baseline total score from the Week 34 total score. Scores will be reported in points. |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 registered outcomesOutcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07878026
GET https://conductscience.org/api/trials/v1/NCT07878026/registered